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A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants (Chime)

2019年9月6日 更新者：Eli Lilly and Company

A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib

The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

111

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 以色列
      • Beer Sheva、以色列、84101
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Jerusalem、以色列、91120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kfar Saba、以色列、44281
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Petah Tikva、以色列、49100
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tel Hashomer、以色列、52621
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zerifin、以色列、6093000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 大韩民国
      • Seoul、大韩民国、138-736
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 德国
      • Heidelberg、德国、69126
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ulm、德国、89081
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 意大利
      • Milano、意大利、20052
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orbassano、意大利、10043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 比利时
      • Aalst、比利时、9300
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gent、比利时、9000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mechelen、比利时、2800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roeselare、比利时、8800
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 法国
      • Montpellier、法国、34295
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toulouse、法国、31059
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • California
      • La Jolla、California、美国、92037
        • University of California - San Diego
      • Los Angeles、California、美国、90048
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sacramento、California、美国、95817
        • University of California, Davis - Health Systems
      • Santa Monica、California、美国、90404
        • UCLA
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Health Sciences Center
    • District of Columbia
      • Washington、District of Columbia、美国、20007
        • Georgetown University Medical Center IRB
    • Florida
      • Fort Myers、Florida、美国、33916-2233
        • Florida Cancer Specialists
      • Saint Petersburg、Florida、美国、33705
        • Florida Cancer Specialists
      • Tampa、Florida、美国、33612
        • H Lee Moffitt Cancer Center
    • Georgia
      • Athens、Georgia、美国、30607
        • Northeast Georgia Cancer Care, LLC
      • Atlanta、Georgia、美国、30322
        • Emory University
    • Iowa
      • Iowa City、Iowa、美国、52242
        • University of Iowa Hospital
    • Kansas
      • Westwood、Kansas、美国、66205
        • University of Kansas Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit、Michigan、美国、48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University Medical Center
    • Montana
      • Billings、Montana、美国、59101
        • Billings Clinic Research Center
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York、New York、美国、10032
        • Columbia University
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Carolinas Medical Center
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • Oncology Hematology Care Inc
    • Oregon
      • Portland、Oregon、美国、97213
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase Cancer Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37404
        • Tennessee Oncology PLLC
      • Memphis、Tennessee、美国、38120
        • The West Clinic
      • Nashville、Tennessee、美国、37203
        • Tennessee Oncology PLLC
    • Washington
      • Kirkland、Washington、美国、98034
        • MS Center at Evergreen
      • Seattle、Washington、美国、98109
        • Seattle Cancer Care Alliance
      • Seattle、Washington、美国、98112
        • Group Health
      • Tacoma、Washington、美国、98405
        • MultiCare Health System
  • 英国
    • Avon
      • Bristol、Avon、英国、BS10 5NB
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Greater London
      • London、Greater London、英国、W6 8RF
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Hants
      • Southampton、Hants、英国、SO16 6YD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Manchester
      • Wythenshawe、Manchester、英国、M23 9LT
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oxford
      • Headington、Oxford、英国、OX3 7LE
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 荷兰
      • Amsterdam、荷兰、1081 HV
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Breda、荷兰、4818 CK
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Badalona、西班牙、08916
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pamplona、西班牙、31008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Valencia、西班牙、46026
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of metastatic Stage IV NSCLC
  • At least 1 measurable extra-central nervous system (CNS) lesion
  • Documented radiographic progression while on continuous treatment with erlotinib monotherapy
  • Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
  • Determined to be MET diagnostic positive (+)
  • Availability of a tumor sample post-erlotinib progression
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Have adequate organ function

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
  • Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
  • Have a serious concomitant systemic disorder or significant cardiac disease
  • Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
  • Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
  • Have major surgery less than 2 weeks prior initiation of study treatment therapy
  • Pregnant or lactating women
  • Have symptomatic CNS metastasis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
药品：Emibetuzumab
Administered IV
其他名称：
  • LY2875358
药品：厄洛替尼
口服给药
实验性的：Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
药品：Emibetuzumab
Administered IV
其他名称：
  • LY2875358

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
大体时间：Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)

次要结果测量

结果测量
措施说明
大体时间
Progression Free Survival (PFS)
大体时间：Baseline to Objective Disease Progression or Death (Up to 24 Months)

PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.

Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Baseline to Objective Disease Progression or Death (Up to 24 Months)
Time to Progressive Disease
大体时间：Baseline to Objective Disease Progression (Up to 24 Months)
Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
大体时间：Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
大体时间：Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
大体时间：Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Overall Survival (OS)
大体时间：Baseline to Death Due to Any Cause (Up to 24 Months)
OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.
Baseline to Death Due to Any Cause (Up to 24 Months)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
大体时间：Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
大体时间：Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
大体时间：Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)

The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.

Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
大体时间：Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
大体时间：Baseline through 30-Day Follow-Up (Up to 24 Months)
Baseline through 30-Day Follow-Up (Up to 24 Months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年8月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2013年7月12日

首先提交符合 QC 标准的

2013年7月12日

首次发布 (估计)

2013年7月16日

研究记录更新

最后更新发布 (实际的)

2019年9月18日

上次提交的符合 QC 标准的更新

2019年9月6日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 14208
  • I4C-MC-JTBC (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD 共享时间框架

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD 共享访问标准

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 临床研究报告（CSR）

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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